Celgene's amrubicin gets orphan status in EU

US drugmaker Celgene says that amrubicin HCl has been designated as an Orphan Medicinal Product by the European Commission for the treatment of small cell lung cancer following the favorable opinion of the European Medicines Agency's (EMEA) Committee for Orphan Medicinal Products (COMP).

Criteria for designation of orphan drug status product require that the product be intended for the treatment of life-threatening or serious conditions that are rare and affect not more than five in 10,000 persons in the European Union. In the EU, small cell lung cancer affects more than 57,000 people and approximately 34,000 new cases of the disease will be diagnosed this year. OD status will provide amrubicin with 10 years of marketing exclusivity following marketing approval for this indication.

In March 2008, the company also announced that the US Food and Drug Administration granted OD status for amrubicin in the treatment of small cell lung cancer.